ChampioNIR® SFA Stent EFS Study

NCT03775226 | Terminated DMC

• 1 other identifier: SFA-Israel-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency of the target lesion at 6 months.

  Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) \>2.4)

  6 months

• Composite rate of freedom

  from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.

  30 Day

Secondary Outcomes (17)

• Primary patency defined by Duplex US

  30 days and 12 months.

• Acute device success

  index procedure

• Acute procedural success

  index procedure

• Acute technical success

  index procedure

• Secondary Patency absence of restenosis which is defined as Duplex US

  30 days 6, 12, 24 and 36 months

Study Arms (1)

Single are

EXPERIMENTAL

This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation.

Device: ChampioNIR® SFA Stent

Interventions

ChampioNIR® SFA Stent DEVICE

The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.

Also known as: ChampioNIR®

Single are

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and of age of legal consent.
• Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80.
• A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
• Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
• Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.
• Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
• Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• The subject is eligible for standard surgical repair, if necessary.
• Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.

You may not qualify if:

• Thrombophlebitis or deep venous thrombus, within the previous 30 days.
• Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
• Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \>50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion.
• Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
• Presence of an ipsilateral arterial artificial graft.
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
• Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
• Required stent placement (in the target or any other lesion) via a retrograde approach.
• Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
• Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
• Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (3)

Hadassah Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 13, 2018
• Study Start: October 27, 2019
• Primary Completion: August 26, 2021
• Study Completion: January 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

IL (3)